Welcome back to Morris Medical Monday: a weekly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.
Today we will continue on the subject of Polarion's MedPack extension, and have a look into MedPack's System Requirement type Work Item.
A system requirement according to clause 5.1 of IEC 62304:2006. Any issue of this type must be linked to its child software requirement, if it the system requirement is fulfilled by software.
The System Requirement Work Item uses the standard Evaluation Workflow.
Traceability & Impact
A System Requirement Work Item has an impact on a Software Requirement.
For more information on traceability and impacts, see the Traceability wiki page.
Work Item Attributes
The following custom fields must be filled out before evaluation can be requested:
The following custom fields must be filled out before evaluation can be finshed and the work item can be closed:
Person(s) to perform, performing or have performed a review.
Short summary of the review. Attachments should be used for additional information.
Last review date
Hidden field automatically set when review has been finshed. Intended to be used for sorting and statistical analysis.
The following checklist must be filled out before evaluation can be finshed and the work item can be closed:
The following table shows the possible resolution values when the work item is closed:
The system requirement has been approved and needs to be implemented.
The system requirement has not been approved. No further action is needed.
The system requirement has become obsolete and is no longer needed.
The work item entry has been discarded. No further attention is needed.